The drug patent linkageage system refers to the system that connects the drug application procedures with the drug patent dispute resolution procedures.The drug patent linkage system that solves drug patent disputes in advance,thus improves the efficiency of patent dispute resolution,at the same time balances the rights and interests of both parts in the pharmaceutical industry,and further achieves the goals of encouraging the innovation and development of the pharmaceutical industry,improving drug accessibility and protecting the people’s right to life and health.China has initially formed the Chinese Approach for drug patent linkage system through the legal regulations such as the Patent Law and the Implementation Measures of the Early Settlement Mechanism of Drug Patent Disputes(Trial).In the process of implementation of China’s drug patent linkage system,some deficiencies are exposed.This paper plans to put forward targeted suggestions for the further improvement of China’s drug patent linkage system by studying and analyzing its development process,basic content and operation practice,combined with the investigation of the actual effect outside the region.In addition to the introduction,this article consists of the following parts:The first part starts with the relevant concept of drug patent linkage system,and clarify the current drug patent linkage system as the core on the basis of drug patent dispute early settlement mechanism,on this basis,combs the analysis and research the relevant platform construction,judicial practice and administrative practice of specific,summarizes the actual system operation,and analyzes its shortcomings.The second part is the comparative study of drug patent linkage system.Through the comparative study of drug patent linkage system in the United States and South Korea and India which resolutely resist drug patent linkage system as a representative,combined with the reality of the pharmaceutical industry development and the drug patent dispute resolution practice effect analysis,its operation practice,this part is about to provide reference for our country drug patent linkage system construction.In the third part,based on the operation of drug patent linkage system in China and the practice of resolving drug patent disputes,some suggestions are made to improve the implementation of the current system in the following directions.First,improve the construction of drug patent information publicity platform to lay the foundation for the smooth operation of drug patent linkage;second,improve the judicial-oriented drug patent dispute resolution mechanism,improve the efficiency of drug patent linkage disputes to approve the effectiveness of drug linkage system;third,improve the Market Exclusivity of the first imitation drug system,implement the incentive of drug patent linkage;fourth,exert the advantages of Chinese mediation system in drug patent dispute settlement,promote the communication and negotiation in the procedure,to complete the deficiencies of the current system design. |